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Meet the Editors

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

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. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

FDA approves first generic iron sucrose injection for treating iron deficiency anemia in CKD patients aged 2 years and older.

FDA approves first generic iron sucrose injection for iron deficiency anemia in CKD

Brensocatib was granted FDA priority review in February 2025 for the small molecule, oral, reversible inhibitor.

FDA approves brensocatib to treat adolescents with non-cystic fibrosis bronchiectasis

FDA accepts priority review of gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients ≥12 years.

FDA accepts priority review for gepotidacin as oral treatment for gonorrhea

Explore essential resources and toolkits for managing the ongoing stimulant medication shortage affecting ADHD treatment and patient care.

A brief review of primary care resources and toolkits for the stimulant shortage

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Steven Sust, MD, is a clinical associate professor of Psychiatry and Behavioral Sciences at Stanford Medicine Children's Health.

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

A new drug application has been filed with the FDA by Johnson & Johnson (J&J) for its investigational targeted oral peptide icotrokinra to treat adults and pediatric patients 12 years or older with moderate to severe plaque psoriasis (PsO), according to a press release from the company.

If approved, this indication would be the first for the peptide that selectively blocks the IL-23 receptor, underpinning inflammatory response in plaque PsO and offering potential in other IL-23–mediated diseases, according to J&J. 

Application submission was based on data from 4 phase 3 studies conducted in the ICONIC clinical development program, including ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), ICONIC-ADVANCE 1 (NCT06143878), and ICONIC-ADVANCE 2 (NCT06220604). 

Data from the phase 3 ICONIC-LEAD study, presented at the 2025 American Academy of Dermatology Annual Meeting, demonstrated that once-daily icotrokinra significantly improved skin clearance in adolescents (≥ 12 years) and adults with moderate to severe plaque PsO. At week 16, 65% of patients receiving icotrokinra achieved an Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear) and 50% achieved a 90% reduction in Psoriasis Area and Severity Index (PASI) score compared with 8% and 4% of placebo recipients, respectively (

Efficacy continued through week 24, with 74% of patients achieving IGA 0/1 and 65% reaching PASI score of 90 (PASI 90). Complete skin clearance was observed in 46% (IGA 0) and 40% (PASI 100) of treated patients. The overall rate of adverse events was comparable between the icotrokinra and placebo groups (49% each), and no new safety signals were reported. 

"People living with moderate to severe plaque psoriasis are seeking options that balance efficacy, safety, and ease of use,” said Robert Bissonnette, MD, chair of Innovaderm Research in Montreal, Quebec, Canada, and ICONIC-LEAD study investigator, at the time of data announcement. "These study results are promising and show the potential for treatment with icotrokinra to offer patients the unique combination of complete skin clearance and a favorable safety profile in a once-daily pill.”

In a study presented at the 2025 Society for Investigative Dermatology Annual Meeting, once-daily icotrokinra demonstrated significant skin clearance in adults and adolescents with moderate plaque PsO involving high-impact areas and as little as 1% body surface area. At week 16, 57% of patients treated with icotrokinra achieved the study’s primary end point—an IGA score of 0/1 with at least a 2-grade improvement from baseline—compared with 6% of those receiving placebo (

Icotrokinra also demonstrated clinical benefit across specific anatomical regions. At week 16, 66% of patients with scalp involvement achieved a scalp-specific IGA score of 0/1 vs 11% on placebo (

 < .001). Among patients with genital PsO, 77% achieved a static Physician’s Global Assessment (PGA) of Genitalia score of 0/1 compared with 21% receiving placebo (

In a smaller subgroup with hand and/or foot involvement, 42% of icotrokinra-treated patients reached a hand/foot PGA score of 0/1 compared with 26% on placebo.

Phase 3 ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies

Top-line results from the phase 3 ICONIC-ADVANCE 1 and 2 studies demonstrated that once-daily icotrokinra met its coprimary end points of achieving an IGA score of 0/1 and a 90% reduction in PASI at week 16 compared with placebo. The studies enrolled patients with moderate to severe plaque PsO and further reinforced the efficacy profile observed in earlier trials.

In addition to meeting the primary efficacy end points, icotrokinra achieved all key secondary end points at weeks 16 and 24, demonstrating superiority over deucravacitinib. These findings support the potential of icotrokinra as an effective treatment option for patients with moderate to severe plaque psoriasis.

“The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences,” said Liza O’Dowd, MD, vice president and immunodermatology and respiratory disease area lead at Johnson & Johnson Innovative Medicine. “Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease.”

Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis. Press release. Johnson & Johnson. July 21, 2025. Accessed July 21, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis

Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis. Press release. Johnson & Johnson. March 8, 2025. Accessed July 21, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis

Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis. Press release. Johnson & Johnson. May 9, 2025. Accessed July 21, 2025. https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-significant-skin-clearance-in-patients-with-difficult-to-treat-scalp-and-genital-psoriasis

J&J is seeking the first approval for the investigational targeted oral peptide to treat patients 12 years or older with moderate to severe plaque psoriasis.

News

J&J submits icotrokinra NDA for plaque psoriasis in patients 12 years or older

According to results from a randomized clinical trial that evaluated emollient intervention in infants not selected for risk of atopic dermatitis (AD), daily emollient application before the age of 9 weeks reduced incidence of AD at the age of 24 months.

According to the study authors led by Eric Simpson, MD, MCR, from the Department of Dermatology at Oregon Health & Science University in Portland, AD imposes a global health burden for children and can be a risk factor for developing food allergy and asthma.

Atopic dermatitis phenotypes and allergic disease development in children

Those who develop AD early in life can carry a risk of developing allergic comorbidities, sleep disturbances, behavioral changes, and mental health disorders and can experience bullying or stigma associated with AD.

"The objective of this current study, the Community-based Assessment of Skin Care, Eczema, and Allergies (CASCADE) trial, was to determine whether once-daily, full-body emollient initiated within the first 9 weeks of life can reduce the cumulative incidence of AD in a community-based population not selected for risk," wrote Simpson and investigators.

The trial was a randomized, decentralized pragmatic clinical trial that featured 1247 infant-parent dyads from 25 community-based pediatric and family medicine clinics that are members of 4 statewide practice-based research networks. 

Dyads were broken up into one of 2 groups: a daily, full-body emollient application daily moisturizer group that started by 9 weeks of age or a control group that did not use emollient. Physician-diagnosed AD recorded in medical records by 24 months of age was the primary outcome of the study.

"In the primary analysis, the risk of diagnosed AD by age [of] 2 years in the intervention was compared with the control groups under an intention-to-treat assumption and missing outcomes were imputed using multiple imputation," wrote the study authors. "The relative risk (RR) was estimated using a generalized linear model with a binomial distribution and log link and reported 

 values from a 2-sided Wald test at the .05 level of significance. Risk differences [RDs] are presented using the 

 commands in Stata version 18 (StataCorp)."

Of the 1247 infants included in the trial, 44.3% were girls. The mean (SD) age at random assignment was 23.9 (16.3) days. At the 24-month mark, the cumulative incidence of AD was 36.1% (SE, 2.1) in the daily moisturizer group and 43.0% (SE, 2.1) in the control group, with an RR of 0.84 (95% CI, 0.73-0.97; 

 = .02). The effect magnitude was larger in the population not at high risk of AD (RR, 0.75; 95% CI, 0.60-0.90; 

A weaker intervention effect was observed for those who had a first-degree blood relative with atopic disease compared with children with a lower risk, though the interaction was not statistically significant. Additionally, protective effect of emollient was modified by a dog in the house, as a stronger effect of protection was observed of the intervention in a subset of families (RD, −14.2; 95% CI, −23.2 to –4.6) than in those without any pets (RD, 0.3; 95% CI, −9.6 to 10.3). 

Skin infections, a secondary outcome, occurred at lower rates in the daily moisturizer group compared with the control group (19.8% vs 21.1%; RR, 0.94; 95% CI, 0.74-1.20), with no statistical difference between groups.

Findings suggest that routine use of emollients for AD prevention could be an approach for families, as 64% of participants reported using emollients before study enrollment.

"This suggests that routine emollient use is part of infant skin care routines for many households in the US. The composition of the emollient likely makes a difference in efficacy, as differences have been observed in skin barrier assessments between ceramide and non–ceramide-containing moisturizers," wrote the authors.

Overall, results demonstrate that full-body emollient application that began in the first 2 months of life reduced the risk of AD development, particularly in those with a family history of AD and those who had a dog in the house.

The investigative team concluded by writing that "further work will be needed on the cost-effectiveness of this approach and implementation strategies" and that "the effect of this approach on allergic comorbidities is also a high priority for future work."

Simpson EL, Michaels LC, Ramsey K, et al. Emollients to prevent pediatric eczema: a randomized clinical trial. 

. Published online July 23, 2025. doi:10.1001/jamadermatol.2025.2357

Fitch J. Atopic dermatitis phenotypes and allergic disease development in children. 

. July 25, 2025. Accessed July 28, 2025. https://www.contemporarypediatrics.com/view/atopic-dermatitis-phenotypes-and-allergic-disease-development-in-children

The study enrolled infants not selected for risk, a population that has been seldom studied with regard to emollient intervention.

Study: Daily emollient for infants could reduce atopic dermatitis incidence

On July 29, 2025, the FDA granted fast track designation to the investigational therapy rezpegaldesleukin (Rezpeg; Nektar Therapeutics) for the treatment of severe to very severe alopecia areata (AA) in adults and pediatric patients 12 years or older with a weight of at least 40 kg.

Rezpegaldesleukin is a biologic candidate designed to target the IL-2 receptor complex to stimulate proliferation of regulatory T cells (Tregs), which may help restore immune tolerance in autoimmune conditions such as AA. Nektar noted that results from multiple trials showed the therapy safely and dose-dependently increased Treg populations. 

"We are pleased that rezpegaldesleukin has been granted fast track designation for the treatment of alopecia areata, adding to its fast track designation in atopic dermatitis," said Jonathan Zalevsky, PhD, senior vice president and chief research and development officer at Nektar. "Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches that could treat the underlying pathogenesis of this disorder."

The FDA’s fast track designation is intended to facilitate the development of treatments for serious conditions that address an unmet medical need. With this designation, rezpegaldesleukin becomes eligible for more frequent meetings with the FDA, written communications on clinical trial design, and potential rolling and priority review. 

Phase 2b Rezolve AA study of rezpegaldesleukin 

The phase 2b Rezolve AA trial (NCT06340360) was initiated in March 2024 and enrolled approximately 90 patients across 30 sites worldwide, including in Poland (62%), Canada (24%), and the United States (14%).

Participants were randomly assigned to receive one of 2 dose regimens of rezpegaldesleukin or placebo over a 36-week induction period. Patients were eligible for the study if they had a diagnosis of severe to very severe AA, defined as 50% or greater scalp involvement based on the Severity of Alopecia Tool (SALT) score at both screening and random assignment. Individuals with diffuse alopecia or an unstable disease course in the previous 6 months were excluded.

The study's primary end point is the mean percentage change in SALT score at week 36. Secondary outcomes include the proportion of patients achieving 50% or more reduction in SALT score, mean SALT improvement at other time points, and the proportion of patients reaching SALT-20 (defined as an absolute SALT score of 20 or less).

"We remain on track to announce top-line data in December from our ongoing Rezolve AA phase 2b study for rezpegaldesleukin in alopecia areata, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational program following the completion of phase 2," added Zalevsky. 

February 2025 fast track designation for atopic dermatitis

Nektar Therapeutics remains on track to announce top-line phase 2 data in December. 

Steven Sust, MD

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